Moderna Withdraws mRNA Flu-COVID Vaccine Application; FDA Orders New Warnings for mRNA Shots

Moderna has voluntarily withdrawn its Biologics License Application (BLA) for its combination seasonal influenza–COVID-19 mRNA vaccine candidate, mRNA-1083, following consultations with the U.S. Food and Drug Administration (FDA). The move comes after the FDA requested additional phase 3 efficacy data, particularly for the influenza component of the vaccine. Moderna plans to resubmit the application later this year once new data from ongoing trials become available, targeting FDA approval in 2026.

The mRNA-1083 vaccine combines Moderna’s next-generation COVID-19 vaccine (mRNA-1283) with its investigational influenza vaccine (mRNA-1010). Recent phase 3 trial results showed the combination vaccine was noninferior to standard flu and COVID-19 vaccines, inducing higher immune responses against several influenza strains and SARS-CoV-2 in adults aged 50 and older. The withdrawal delays the review timeline, as the FDA emphasized the need for more robust efficacy data before proceeding.

In a related development, the FDA has directed both Moderna and Pfizer to update their COVID-19 mRNA vaccine labels to include warnings about the risk of heart injury, specifically myocarditis and pericarditis, which have been observed at higher rates in teenage boys and young men. This regulatory action follows ongoing debate and research into the long-term safety of mRNA vaccines, including concerns about the persistence of vaccine-derived spike proteins and potential risks of DNA integration. The FDA’s updated warnings reflect a precautionary approach as new studies are expected to further investigate these safety issues.

These developments highlight the evolving regulatory landscape for mRNA vaccine technology as manufacturers and health authorities respond to both scientific findings and public concerns. Moderna remains committed to advancing its mRNA vaccine pipeline, with plans to address the FDA’s requirements and bring new combination vaccines to market in the coming years.